Scientific Publications by FDA Staff

J Infect Dis 2007 Sep 1;196(5):692-8

Randomized trial of inactivated and live polio vaccine schedules in guatemalan infants.

Asturias EJ, Dueger EL, Omer SB, Melville A, Nates SV, Laassri M, Chumakov K, Halsey NA

Halsey NA (reprint author), Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Int Hlth, 615 N Wolfe St,W5515, Baltimore, MD 21205 USA Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Int Hlth, Baltimore, MD 21205 USA US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA Univ Valle Guatemala, Ctr Hlth Studies, Guatemala City, Guatemala Hosp Roosevelt Guatemala, Dept Pediat, Guatemala City, Guatemala Univ Nacl Cordoba, Fac Ciencias Med, Inst Virol Dr JM Vanella, RA-5000 Cordoba, Argentina

BACKGROUND: The immunogenicity of inactivated poliovirus vaccine (IPV) in developing countries is not well documented. This study compared the immune response to IPV with that to oral poliovirus vaccine (OPV) in Guatemalan infants. METHODS: This was an open-label, randomized comparison of IPV only, OPV only, or IPV followed by OPV in Guatemalan public health clinics. Serum samples were tested for neutralizing antibodies, and stool samples were tested for Sabin strain polioviruses. RESULTS: Seropositivity rates 2 months after 2 doses of IPV were 98%-100% for polio types 1, 2, and 3 and were 97.1%, 99.3%, and 92.1% for OPV-only recipients (P<.001 for the response to type 3). One month after the third dose, 100% of IPV-only recipients had protective antibodies against all 3 types, compared with 99%, 100%, and 97% against polio types 1, 2, and 3 respectively, among recipients of OPV only. Infants who received IPV only had higher geometric mean titers than infants who received OPV only. Maternal antibodies lowered the final antibody responses to IPV but did not prevent the development of protective levels of antibody. Of 191 stool samples from infants who received IPV only, 5 (2.6%) were positive for poliovirus vaccine strains. CONCLUSIONS: IPV alone and IPV followed by OPV are safe and effective for Guatemalan infants.